Key Accountabilities:

• Prepare and submit local documentation to regulatory authorities.
• Ensure compliance with international regulations, including FDA, EMA, and other relevant agencies.
• Collaborate with internal teams to gather necessary information for regulatory submissions.
• Monitor changes in Local regulations and assess their impact on the company’s products.
• Provide guidance on regulatory requirements for product registration in foreign markets.

Qualification Requirements:

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• Bachelor’s degree in Pharmacy or a related field.
• Experience from 1 to 3 years.
• Must have Experience/Knowledge in CTD file preparation for Export.
• Proficiency in spoken and written English.
• Good organizational and communication skills.
• Negotiation and teamwork abilities.
• Time management and planning proficiency.
• Presentation, creativity, and innovation skills.
• Responsibility and adaptability.

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